RELAX Anaesthetics: the Effect of a Bespoke Relaxation App on Stress Levels in Children Undergoing Anaesthesia (RELAX-A)

RELAX Anaesthetics is a randomised clinical trial assessing the effectiveness of using an iPad app with art, music and games to relax and distract children, reduce anaesthetic induction time and make drug cost savings prior to surgery.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Other: iPad app containing art, music and games; Other: Toys, books and games

Detailed Description

The most distressing part of a parent's experience in hospital is watching a child undergo intravenous cannulation.1 This is commonly performed in the anaesthetic room prior to induction of anaesthesia. At Chelsea and Westminster Foundation Trust (CWFT) over 5000 children undergo operations every year. Traditional methods of distracting the child during have included blowing bubbles, storybooks, and a variety of toys and games. These methods are not always effective and may present an infection risk due to inability to clean between uses.

The use of an android/iPad provides a platform for effectively distracting the child with a choice of games, video and music, with the advantage of being cleaned between uses. Users of this platform are required to select the application that is most appropriate for the age, sex, method of anaesthesia, and compliance level of the child. To assist with this, the investigators have developed an application system that will select a range of entertainment applications appropriate for each child based on these four variables and hopefully help to keep children calm before their operations.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW10 9HS
    • Chelsea and Westminster Hospital
  • London, United Kingdom, SW7 2BS
    • Centre for Performance Science, Royal College of Music

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children ages 2 -12 years
• requiring general anaesthesia
• ASA assessment of fitness for surgery score 1 - 3

Exclusion Criteria:

• intravenous cannula already in situ
• play therapist already in use
• anaesthetist refusal to participate
• parental / patient refusal to participate
• sedative or opiate pre-med already administered
• not requiring general anaesthesia
• ASA assessment of fitness for surgery score 4 or 5

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iPad app containing art, music and games; On entry to the anaesthetic room, children will be given an iPad (the intervention) with art, music and games to distract them. A nurse will help them engage with the iPad whilst the anaesthetists complete the anaesthetic. Once the child falls asleep, the iPad will be removed. This process is anticipated to last between 3 and 30 minutes depending on the time taken to anaesthetise the child.	Other: iPad app containing art, music and games; An iPad app that takes demographic information on a child and suggests suitable art, music and games for use by the anaesthetist and nurse to distract them during anaesthetics
Active Comparator: Toys, books and games; On entry to the anaesthetic room, children will be given toys or games to distract them. A nurse will help them play whilst the anaesthetists complete the anaesthetic. Once the child falls asleep, the games will be removed. This process is anticipated to last between 3 and 30 minutes depending on the time taken to anaesthetise the child.	Other: Toys, books and games; Games, books and toys used to distract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Yale Preoperative Anxiety Scale	An observational scale assessing distress levels	Change between baseline and completion of cannulation (2 hours later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paediatric Anaesthetic Emergence Delirium Score	An observational scale assessing delirium levels post surgery	Single measurement taken from observation over 15 minutes immediately following surgery
State Trait Anxiety Inventory	A psychological scale measuring parental anxiety before and following the anaesthetic procedure for their child	Change between baseline and completion of cannulation (2 hours later)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to induction	Time taken to cannulate and anaesthetise a child	Duration of anaesthetics timed (from entering the anaesthetics room to successful anaesthetisation of child (estimated 3-30mins in the room)
Drugs cost	Cost of induction agents during anaesthetic procedure	Drugs used from the time the child enters the anaesthetics room to successful anaesthetisation (estimated 3-30mins in the room)

Collaborators and Investigators

• Sponsor: Royal College of Music
• Collaborators: Chelsea and Westminster NHS Foundation Trust
• Investigators: Principal Investigator: Peter Brooks, Chelsea And Westminster Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Estimate): October 27, 2015
• Last Update Submitted That Met QC Criteria: October 26, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: RELAX2015